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The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.
The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINIject implant | Device | MINIject implant is used to reduce intra-ocular pressure (IOP) in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation | Change of Medicated diurnal IOP [mmHg] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication | 6 months after implantation surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zubair Hussain, PhD | iSTAR Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maxivision Eye Hospital | Hyderabad | Telangana | 500034 | India | ||
| Clinica de ojos Orillac-Calvo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33011690 | Derived | Denis P, Hirneiss C, Durr GM, Reddy KP, Kamarthy A, Calvo E, Hussain Z, Ahmed IK. Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial. Br J Ophthalmol. 2022 Jan;106(1):65-70. doi: 10.1136/bjophthalmol-2020-316888. Epub 2020 Oct 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Implant | MINIject implant: MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
26 patients met eligibility criteria and underwent MINIject implantation surgery. These participants represent safety reporting population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Implant | MINIject implant: MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation | Change of Medicated diurnal IOP [mmHg] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication | patients who received MINIject implant and were present at both Baseline and 6-month follow-up visit | Posted | Mean | Standard Deviation | mmHg | 6 months after implantation surgery |
|
2 years post-implantation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implant | MINIject implant: MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | MedDRA (ver. 20.0) | Systematic Assessment | death during sleep from unknown cause |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior Chamber inflammation | Eye disorders | MedDRA (ver. 20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zubair Hussain, VP Clinical and Regulatory Affairs | iSTAR Medical | +3210771658 | zubair@istarmed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2017 | Dec 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Panama City |
| Panama |
| implant not received |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| primary open-angle glaucoma | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 2 |
| 26 |
| 2 |
| 26 |
| 21 |
| 26 |
|
| pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (ver. 20.0) | Systematic Assessment | pancreatic carcinoma resulting in death |
|
| Visual acuity reduced | Eye disorders | MedDRA (ver. 20.0) | Systematic Assessment |
|
| Visual Field Defect | Nervous system disorders | MedDRA (ver. 20.0) | Systematic Assessment | >3dB (decibel) worsening from baseline value, even if transient, reported |
|
| Intraocular Pressure increased | Investigations | MedDRA (ver. 20.0) | Systematic Assessment | *Only one patient had a mean intraocular pressure (IOP) increase, which fulfilled the protocol definition of substantial IOP increase (≥10 mmHg higher than screening IOP after the 1-month postoperative visit). |
|
| Lenticular opacities | Eye disorders | MedDRA (ver. 20.0) | Systematic Assessment |
|
| Hyphaema | Injury, poisoning and procedural complications | MedDRA (ver. 20.0) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (ver. 20.0) | Systematic Assessment |
|
| eye pain | Eye disorders | MedDRA (ver. 20.0) | Systematic Assessment |
|
| eye pruritus | Eye disorders | MedDRA (ver. 20.0) | Systematic Assessment |
|